CLINICAL TRIALS GUIDE FOR TRAINEES Guidance to support NIHR trainees interested in getting involved in clinical trials CONTENTS Introduction ................................................................................................................ 1 General ......................................................................................................................... 2 Fellowships and clinical trials ................................................................................ 4 Approvals ..................................................................................................................... 5 Methodologies ........................................................................................................... 8 Teams and management ........................................................................................ 8 Patient and public involvement ........................................................................... 9 Clinical Trials Units ..................................................................................................10 Finances .....................................................................................................................11 Additional support .................................................................................................11 Summary of useful links ........................................................................................12 INTRODUCTION Clinical trials, compared to observational studies, are considered by many to be the gold standard method for evaluation of healthcare interventions. They contribute significantly to relevant research evidence developed by the National Institute for Health Research (NIHR) to support the NHS in England and other care providers. However, clinical trials are complex and many researchers, particularly those in the early stages of their career, find it challenging to know where to start, either to contribute to or lead a trial. After conducting an internal report on trainee engagement in clinical trials, the NIHR Trainees Coordinating Centre began a project to develop a source of information to support individuals interested in pursuing a research career that involves the delivery of clinical trials. This booklet is the outcome of the first stage of the project which was to determine which questions aspiring trialists need answering ahead of starting their journeys into clinical trials. Through collaboration with experts across the NIHR and conversations with existing trainees we have put together a list of questions (and answers!) that we hope trainees will find useful, as well a list of useful links to resources for further information. We are pleased to release the first version of this booklet to mark International Clinical Trials Day 2015. As our project continues we will update this guide so that it includes the most useful and up-to-date information on clinical trials for trainees. If you have any suggestions or feedback then please email [email protected] or tweet us @NIHR_trainees. This guide was developed with input from a working group comprising: Liz Tremain, Senior Programme Manager, NIHR Evaluation Trials and Studies Coordinating Centre Professor Lelia Duley, Director, Nottingham Clinical Trials Unit Professor Lesley Stewart, Director, Centre for Reviews and Dissemination, York Professor Andrew Fisher, Associate Dean for Clinical Academic Training Newcastle University Dr Wendy Baird, Director, NIHR Research Design Service for Yorkshire and the Humber Dr Maria Bryant, Leeds Clinical Trials Unit Dr Duncan Harding, NIHR Clinical Lecturer, IoP, King’s College London Dr Carsten Flohr, NIHR Clinician Scientist, King’s College London Dr Angelos Kolias, Specialty Registrar Neurosurgery, University of Cambridge We hope you find this information helpful and we wish you luck in your future trials! - the NIHR Trainees Coordinating Centre 1 ← GENERAL Contract Research Organisation. Your The NIHR is committed to avoiding waste What local registered CTU will also be a good in research and unjustified duplication of point of contact about clinical trials being a trial is unlikely to be funded. The NIHR performed in your area. and other research funders recommend exactly is that all clinical trials should start with a What is generally involved in systematic review of the existing research conducting a clinical trial? evidence. This may reveal that there is meant by already sufficient high-quality research A clinical trial should be considered when evidence to answer your research there is uncertainty as to which of a range question (in which case you will need to the term of treatment options or preventative think of a new trial or project) or provide strategies is more effective. A team sound information to justify your research, of investigators are responsible for and potentially help with your trial design. ‘clinical conducting a clinical trial and this requires meticulous planning. If a clinical trial isn’t appropriate, what are my other options? trial’? Once the case for a new clinical trial has been made on medical, ethical and Clinical trials are not always the most A clinical trial is a research project that financial grounds then the trial needs to appropriate option to further your compares two or more treatments in be designed so that it will provide the research and to support the development patients with a particular condition or highest possible quality of evidence to and evaluation of new treatments. A at risk of a condition to help generate guide future decision making. Trial design pilot study to assess the feasibility of high quality evidence about which is the is a multi-disciplinary activity involving conducting a clinical trial is often needed. more effective treatment or preventative input from clinicians, trial methodologists, The pilot study will allow the team of strategy. The treatment being investigated pharmacists, statisticians and health investigators to determine the likely in a clinical trial can be a medicinal economists among others. difficulties in performing a full clinical product, a procedure, a device or another trial and also inform the calculations on type of therapeutic intervention. Clinical After the clinical trial is designed, sample sizes in a full clinical trial to be trials are an essential part of the process the funding to pay for the trial to be done. of evidenced based practice and can help conducted must be identified either from guide treatment decisions for both health industry, who may fund a clinical trial An observational study may be a more care professionals and patients. Clinical as part of the development pathway appropriate option if there is uncertainty trials are an important part of the pathway for a new medicinal product, device or about the most robust endpoints to use by which new medicinal products can technology or from a research funding in a clinical trial, or if the mechanism of obtain a licence from MHRA and become body such as NIHR or Medical Research a potential new treatment has not been available for use as a new treatment in Council or from a charity such as Cancer established. patients. Research UK or the British Heart Foundation. After funding is secured, What would be a realistic timescale I like the idea of becoming involved in then all the necessary permissions such for a clinical trial and does this differ clinical trials, but don’t know how to as research ethics approval and NHS at all? go about this. Where do I start? research governance approval must be sought. The time required to design a clinical trial, Clinical trials are performed widely produce the detailed trial protocol and across the NHS and the Research and Training on the legal responsibilities when secure all permissions is substantial and Development Department in your local conducting a trial can be provided locally can take 6-12 months to complete. NHS Trust will have a record of all the as a Good Clinical Practice (GCP) course clinical trials active in your hospital. which is offered by your local NIHR The time required to perform the clinical Many trials are also registered on Clinical Research Network. trial will vary widely and will depend on national and international databases that the sample sizes needed, the frequency are searchable and can identify trials How will I know whether or not a by which participants are recruited and in specific diseases or using specific clinical trial is appropriate for my the follow up period for each participant in treatments. These include the NIHR research? the study. research network databases, Clinical Trials.gov, UK Clinical Trials Gateway and Before embarking on a clinical trial it is How many projects should I become EudraCT. important to establish whether a new involved in? trial is indeed needed. You should check Many clinical trials, especially those what research has already been done. If new to clinical trials, it is best to get involving a new medicinal product or Are there existing trials that may provide involved in one clinical trial initially and involving multiple sites, are supervised enough evidence to answer the question fully understand the processes involved by a Clinical Trials Unit (CTU) or a that you wish to address? in more detail. → 2 The following simple checklist may help you decide whether a clinical trial is appropriate for your research: Step 1 – establish whether a relevant systematic review already exists ► If yes, and this resolves the clinical uncertainty